Feasibility Study of the Advanced Symptom Management System (ASyMS) in Canadian Cancer Patients

Cancer Clinical Trial

— ASyMS-Can  

Official title:

Adaptation, Feasibility and Acceptability Study of the Advanced Symptom Management System (ASyMS) Mobile Health Intervention to Reduce Chemotherapy Toxicities in Canadian Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03335189
• Other study ID #: CAPCR ID: 17-5367.0
• Status: Completed
• Phase: N/A
• Start date: November 15, 2017
• Est. completion date: May 28, 2019

Study information

• Verified date: June 2019
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Advanced Symptom Monitoring and Management System - Canada (ASyMS-Can) is a remote phone-based symptom management system that prompts patient self-care and clinician telephone triage and intervention based on alerts for managing cancer treatment side effects such as nausea and vomiting, fatigue, etc. ASyMS-Can is an android phone-based application that is given to patients to self-report their symptoms using a patient reported outcome symptom questionnaire and level of severity daily, on a secure mobile android phone, from home or outside of clinics. Based on back-end computations, patients receive automated self-care notifications on their mobile phones with advice on self-care for mild to moderate severe symptoms. The system also in the case of severe symptoms will alert the designated clinic nurse to prompt electronic telephone triage and intervention (yellow alert response in 4 hours or within 30 minutes for severe symptoms-red alert).

Description:

In addition, patients can access a self-care library and symptom graphs (detailing trends in individual symptoms experienced) through the ASyMS-Can patient phones. If the incoming symptom reports are of clinical concern, the server software will generate two levels of alerts (amber& red) that will be sent to the designated nurse, who will receive alerts on a dedicated ASyMS-Can nurse handset (mobile phone). The nurse will view the patient's symptom reports on a secure web page, and contact the patient directly at home by telephone, guided through a decision-support algorithm on the web-based platform to systematize the triage based on the COSTARS guideline, facilitating the initiation of "real-time" clinical interventions. An "amber alert", which requires response within 4 hours, indicates that the symptom(s) are not severe or life-threatening but early intervention might prevent further symptom progression. The second level of the triage alert, 'red alert', will be sent to the nurse for severe symptoms and will require response within 30 minutes of receipt of the alert

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: May 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients diagnosed with early stage breast, colorectal, and lymphoma (Hodgkin's [HD], non- Hodgkin's [NHL].

2. Scheduled to receive 2-, 3- or 4-weekly chemotherapy protocols (i.e. chemotherapy administered at repeated cycles of 14, 21 or 28 days, respectively).

3. Scheduled to receive a minimum of 3 cycles of systemic chemotherapy (any regimen); adjuvant or neo-adjuvant on an out-patient basis;

4. Adults >=18 years of age;

5. Able to provide written consent and willing to participate;

6. Adequate ability to use or be trained in use of a mobile phone for symptom reporting

Exclusion Criteria:

1. Enrolled/receiving an investigational treatment;

2. Scheduled to receive concurrent radiotherapy during chemotherapy treatment.

3. Scheduled to receive weekly chemotherapy protocols. In addition, patients who shift from a 2-, 3- or 4-weekly protocol to a weekly protocol during chemotherapy will be excluded from further participation in the study.

4. Any distant metastasis based on Ann Arbor or TNM staging

5. Unable to speak/read/write English sufficiently to complete study measures.

6. Unable to complete study measures due to a pre-existing disability (e.g. visually impaired)

7. Cognitive impairment/severe pre-existing emotional issues as assessed by the treatment team which may impede completion of study measures.

8. Low performance status (ECOG > or =3)

Related Conditions & MeSH terms

• Cancer
• Supportive Care

Intervention

Device:
• ASyMS-Can
Data reported by the participants will be sent to a secure, encrypted clinical central server hosting the risk-alerting algorithms. The web interfaces will provide a clinical portal for the nurses to screen and follow any alerts being triggered, as well as review patient-specific information. Based on these back-end computations, participants will receive automated self-care notifications on their mobile phones. If incoming symptom reports indicate severe adverse effects a designated clinic nurse will receive an 'amber alert', or 'red alert', that will require response within 30 minutes. Nurses will handle alerts during business hours (9 am to 5 pm). After-hour alerts will be sent to the oncologist or nursing supervisor on call as per usual care. Patients will be instructed that clinicians will not receive alerts during the evening hours or night and instructed to follow usual practice of contacting their family physician, or oncologist on call, or call 911, as required.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of recruitment	Recruitment Rate (RRa)	Recruitment rate aim is 7-8 patients/month, for 1 year.
Secondary	Symptom Severity	Symptom severity will be measured using the Memorial Symptom Assessment Scale (MSAS). The MSAS is a multidimensional self-report questionnaire that evaluates 32 physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week.	Baseline (within 1 week before 1st chemotherapy cycle). Mid-way each chemotherapy cycle, (Day 6-8, 9-11, or 13-15 - dependent on number of days in the chemotherapy cycle).
Secondary	Chemotherapy Self-Management Behaviours	Chemotherapy Self-Management Behaviours will be measured using the Leuven questionnaire for self-care behaviours during chemotherapy (L-PaSC). The L-PaSC is a 22-item instrument with 7 themes that capture the most relevant aspects of patient self-care during chemotherapy.	Midpoint of treatment cycle (Week 3-4, or 7-8 - dependent on chemotherapy regimen being given).
Secondary	Self-Efficacy for Coping	Self-efficacy will be measured using the Cancer Behavior Inventory (CBI-B) which is a 12-item unidimensional instrument designed to assess coping self-efficacy of cancer patients.	Baseline (within 1 week before 1st chemotherapy cycle), midpoint of treatment cycle (Week 3-4, or 7-8 - dependent on chemotherapy regimen being given), and end of treatment (Week 6-8 or 14-16-dependent on chemotherapy regimen being given).
Secondary	Psychological Distress	Using the Depression, Anxiety and Stress Scale (DASS21) which contains 21 items for self-reporting for measuring a range of symptoms common to both depression and anxiety. Each item is scored from 0 (did not apply to me at all over the last week) to 3 (applied to me very much for most of the time over the past week).	Baseline(within 1 week before 1st chemotherapy cycle), midpoint of treatment cycle (Week 3-4, or 7-8 - dependent on chemotherapy regimen being given), and end of treatment (Week 6-8 or 14-16-dependent on chemotherapy regimen being given).
Secondary	Information and Support Needs	Using the Cancer Treatment Scale (CaTS) that is a two factor, 25-item measure that assesses sensory/psychological concerns and procedural concerns relating to cancer treatment.	Baseline(within 1 week before 1st chemotherapy cycle), midpoint of treatment cycle (Week 3-4, or 7-8 - dependent on chemotherapy regimen being given).
Secondary	Health Related Quality of Life	EuroQual-5D-5L (EQ-5D-5L). The questionnaire offers 5 levels of response for 5 dimensions including Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression.	Baseline(within 1 week before 1st chemotherapy cycle), midpoint of treatment cycle (Week 3-4, or 7-8 - dependent on chemotherapy regimen being given), and end of treatment (Week 6-8 or 14-16-dependent on chemotherapy regimen being given).
Secondary	Health Service Utilization	Including days in hospital, ED visits, urgent care use, unscheduled clinic visits) self-reported by patients at end of each treatment cycle and calculated as group proportions over the entire course of treatment.	End of each chemotherapy cycle (Week 2-3, or 4-5 - dependent on chemotherapy regimen being given).
Secondary	Acceptance, Patient User/Satisfaction, System Usefulness, Information Quality and Interface Quality of User Interface	Using the Post-Study System Usability Questionnaire (PSSUQ) that consists of 16 items which produce four scores—one overall and three sub-scales. The questionnaire designed to assess users' perceived satisfaction with computer systems or applications. The self-administered questionnaire are composed of multiple separate items organized into scales, with each scale assumed to measure an attribute or attitude dimension is a common approach to usability evaluation.	End of study (Week 16)
Secondary	Clinicians' acceptance	using the Treatment Evaluation Inventory Short-Form (TEI-SF)	End of study (Week 16)